Investigation of Formulation and in-Process Parameters of Ambrisentan Tablets

OBJECTIVE To optimize the prescription of ambrisentan tablets. METHODS Drug excipients interactions were evaluated to determine the type of excipients, orthogonal design was used to observe the appearance and dissolution of tablets then to determine the optimal prescription, and to compare the dissolution curves in four different pH mediums. and the accelerated stability test was also carried out. RESULTS The optimized rescription of ambrisentan tablets were determined. In various dissolution media with different pH value, the dissolubility curves of ambrisentan tablets between self-prepared preparations and reference VOLIBRS were similar. Result of 6 month accelerated test was not significant different from that of 0 month accelerated test. CONCLUSION The formulation is reasonable, and the preparation is stable.